Wonderville - Medical Device Regulatory Affairs

Quality System Documentation

QSD is a paper-based evaluation that serves as a substitute for the QMS (formerly GMP).

The TFDA issues QMS certificates for manufacturing sites in Taiwan and QSD certificates for manufacturing sites outside Taiwan.

With the exception of a few low-risk, non-sterile medical devices, QSD is required for most medical device licenses. QSD and license applications can be submitted and reviewed simultaneously; however, QSD approval is required before the TFDA can approve the license application.

QSD must be renewed every three years. The renewal process mirrors the application for a new QSD in terms of both cost and duration.

Required Documents for QSD

Application Type	Standard	US Abbreviate	EU Technical Cooperation Program	Japan Abbreviate	Essential
1. Application forms 2. Medical device distributor certificate 3. General information 4. ISO 13485 certificate 5. Product manufacturing flowchart 6. DMR list	V	V	V	V	V
Plant layout diagram	V			V	V
Layout of production area for each product item	V			V	V
Quality manual	V			V	V
Document master list	V			V	V
Quality SOPs	V				V
CFG		V
EIR audit report		V
FSC			V
Latest inspection report issued by the EU NB partners			V
On-site inspection reports issued by PMDA or RCBs				V
Device Master Records List	V	V	V	V	V

US Abbreviation / EU TCP / Japan Abbreviation: Available to manufacturing sites in these regions that meet the respective requirements.
EU Technical Cooperation Program: Includes manufacturing plants in Switzerland and Liechtenstein.
Essential Mode: Limited to the scopes in the annex of Article 78 of the Medical Device Quality Management System Regulations and requires fewer SOPs than Standard Mode.
EIR Audit Report: Can be replaced by an MDSAP report when criteria are met.

Medical Device License

Medical devices are classified into three categories based on their risk levels. Devices without a previously approved equivalent in Taiwan are considered new and will undergo a longer review process.

Class 1	Class 2	Class 3	New Medical Device
(Low Risk)	(Medium Risk)	(High Risk)	(Without a previously approved equivalent product in Taiwan)

按此處以編輯.

Good Distribution Practice

Under Article 24 of the Medical Devices Act, Medical Device Good Distribution Practice (GDP) is implemented to strength the supply chain management of medical device and to ensure the quality of medical devices is maintained during storage, transportation, and sales.

Effective May 1, 2023, medical device dealers holding licenses for 45 device categories, along with their authorized importers, must establish a system compliant with GDP. Dealers may only wholesale, import, or export after passing an inspection by the central competent authority and receiving GDP approval.

Violations may result in fines ranging from NT$30,000 to NT$1,000,000 under Article 70 of the Medical Devices Act.

	GDP Application
Application Process	Medical device dealer submits application. TFDA accepts application and conducts initial review. Case assigned to authorized third-party agency. Audit plan is issued by third-party agency and confirmed by the dealer. On-site audit is conducted by TFDA and third-party agency. Audit result Pass: The dealer shall propose corrective actions for audit deficiencies. After the corrective actions are reviewed and confirmed by TFDA and third-party agency, approval letter will be issued. Fail: The dealer may request an appeal.
Required Documents for Application	Application form in duplicate and below attachments Activities information Distribution process flowchart (including outsourced activities) Managements and organization chart Distribution system document master list Main equipment List Layout (details shall be included, e.g., staff/material flows and incoming/dispatching area) Medical device list Medical device dealer certificate Quality manual Distribution system document master list and procedural documents Original approval letter (for renewal case)
Application Fee	NT$30,000 (One warehouse included. For each additional warehouse that requires on-site inspection, an additional fee of NT$10,000 will be charged. The warehouses that require on-site inspection will be determined by TFDA.)
Validity Period	The validity period of GDP approval is 3 years. Those who need a renewal shall apply between 6 to 12 months before the expiry date.
References	Medical Devices Act Enforcement Rules of Medical Devices Act Regulations of Medical Device Good Distribution Practice Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License Regulations for Reporting Serious Adverse Events of Medical Devices Regulations for Medical Device Recalls

What can we do for you?

Wonderville has obtained TFDA GDP certification and have sufficient knowledge and experience to help you build a quality system complies with GDP.

Commonly asked question

1. Q: What is the difference between listing and licensing for Class I devices?
A: Starting in October 2021, certain scopes will be registered through listing instead of licensing. Listings must be updated annually, while licenses require renewal every five years.

2. Q: Are there additional rules for medical devices manufactured in China?
A: If your product is manufactured in China, you must confirm that it is not listed among the restricted items by the International Trade Bureau of Taiwan's Ministry of Economic Affairs before beginning the application process.

3. Q: Are there any qualifications required to apply for a medical device license/listing in Taiwan？
A: To apply for a medical device license:
(a) The company must hold a medical device distributor certificate that includes the "import" scope, with at least one import technician listed. Consult your accountant in Taiwan for assistance in company setup.
(b) Except for certain low-risk, non-sterile devices, the manufacturing site's Quality System Documentation (QSD) must be approved before the license is granted.

4. Q: I am a license holder, but I have a distributor in Taiwan. Can another company use my license?
A: Yes, the license holder can authorize another distributor to import medical devices. Both companies must apply for "import authorization" from the TFDA. Once approved, both companies can use the license to import products into Taiwan.

5. Q: I would like to import a Chinese-made medical device approved by CFDA. What do I need to provide?
A: You will need to provide:
(a) A medical device distributor certificate with the "import" scope. Your company must have a registered "technician" with the local Department of Health.
(b) Quality System Documentation (QSD).
(c) A Free Sale Certificate issued by the Chinese health authority, stating your product is approved in China, and it must be legalized.
(d) Check the CCC code with the Department of Customs. You can verify the code at this link before filing an official request.
(e) Product registration documents including Free Sale Certificate (FSC), Letter of Authorization (LOA), QSD, preclinical test reports (e.g., functional tests, biocompatibility, sterilization validation, software validation), product information (e.g., engineering drawings, materials, specifications), and final QC.

6.Q: Do I need a GDP certificate?
A: Starting May 2023, 45 categories of medical devices will require GDP certification. You can find the list of these devices here.